Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Recruitment Maneuver on Functional Residual Capacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208737
Recruitment Status : Completed
First Posted : December 23, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Nuzhet Mert Senturk, MD, Prof, Istanbul University

Brief Summary:

Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units.

The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.


Condition or disease Intervention/treatment Phase
Anesthesia Surgery Atelectasis Procedure: recruitment maneuver Not Applicable

Detailed Description:

An ICU-ventilator capable to measure the FRC will be used for the mechanical ventilation in patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved with TIVA.

FRC will be measured in different steps of the operation. In the study group, a recruitment manover will be applied to evaluate its effects on FRC.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Comparing Effects of Recruitment Maneuver on Functional Residual Capacity in Patients Undergo Laparoscopic Surgery : A Randomized Prospective Study.
Actual Study Start Date : December 23, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : June 1, 2020

Arm Intervention/treatment
No Intervention: control group

3 FRC measurements will be perforemed, whereby : First measurement; after aneshesia induction and intubation. Second measurement; after pneumoperitoneum Third measurement; end of the operation

After the operation,Postoperative Room Air Test (RAT) will be applied.

Experimental: study group

5 FRC measurements will be performed We will apply recruitment maneuver two times to patients with 30cmH2O pressure for 15 seconds .

First Recruitment maneuver will be applied after the fşrst measurement of FRC following intubation Second Recuitment maneuver will be applied at the end of operation

First FRC measurement after anesthesia induction and intubation. Second FRC measurement after first recruitment maneuver Third FRC measurement; after pneumoperitoneum Fourth FRC measurement before second recruitment maneuver Fifth FRC measurement after second recruitment maneuver and at the end of operation

Procedure: recruitment maneuver
30 cmH2O pressure 15 seconds




Primary Outcome Measures :
  1. Comparison of FRC measurements at beginning and end of anesthesia [ Time Frame: within max 5 minutes after the intubation and with max 5 minutes before the extubation ]
    First FRC will be measured after ; the last FRC will be measure bedore the extubation


Secondary Outcome Measures :
  1. Positive room air test [ Time Frame: in recovery room 30 minutes after operation ]
    in recovery room when patient modified aldrete score ≥ 9 patient SPO2 when breathing in room air If patients' spo2 value ≤ 96%, named as room air test positive



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery

Exclusion Criteria:

  1. <18 years old
  2. >65 years old
  3. denial of patient
  4. patients having one of: lung disease, cardiac failure, severe cardiac valvular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208737


Locations
Layout table for location information
Turkey
Istanbul University
Istanbul, Turkey, 34069
Istanbul University, Department of Anesthesiology
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
Layout table for investigator information
Principal Investigator: Elif Aygun, MD Istanbul University
Layout table for additonal information
Responsible Party: Nuzhet Mert Senturk, MD, Prof, Prof.Dr., Istanbul University
ClinicalTrials.gov Identifier: NCT04208737    
Other Study ID Numbers: 2018/938
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases